Rami Fakhoury
Senior Cra 1 @IQVIA
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WORK HISTORY
Senior Cra 1 @IQVIA
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with Good Clinical Practice.• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Ensure copies/originals site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator\'s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.
EDUCATION
University of Westminster
Bachelor's degree, Pharmacology & Physiology
UCL
Master's degree, Drug Discovery and Development
ABOUT RAMI FAKHOURY
An experienced senior clinical trials monitor with experience working on clinical trials within the healthcare and pharmaceutical industries across early and late phase studies in oncology and neurology. A strong research professional with a Master\'s degree in Drug Discovery and Development from UCL.
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